Firm. Any partnership, association, or other unincorporated business organization. Food Safety and Inspection Service. The Food Safety and Inspection Service of the Department. Further processing. Smoking, cooking, canning, curing, refining, or rendering in an official establishment of product previously prepared in official establishments. Immediate container. The receptacle or other covering in which any product is directly contained or wholly or partially enclosed. Import Field Office (IFO). The office of the supervisor of import inspection activities for a particular importing field area. The areas are as follows: IFO #1. Boston, MA-Covering the States of IFO #4. Baltimore, MD-Covering the States of Maryland, Delaware, West Virginia, Virginia and Kentucky. IFO #5. Charleston, SC-Covering the States of Tennessee, North Carolina, South Carolina, Georgia and Florida (excluding south Florida). 11FO #6. Miami, FL Covering the areas of southern Florida, Puerto Rico and the Virgin Islands. 11FO #7. New Orleans, LA-Covering the States of Louisiana, Mississippi, Alabama, Arkansas, Texas, Oklahoma, Kansas, New Mexico and Colorado. 11FO #8. San Pedro, CA-Covering the States of Hawaii, Arizona, Utah, Nevada, the area of southern California, American Samoa, Guam, and the Northern Marianas. 11FO #9. Tacoma, WA Covering the States of Washington, Oregon, Idaho, Montana, Wyoming, North Dakota, South Dakota, Alaska, and Nebraska, and the area of northern California. 1IFO #10. Detroit, MI-Covering the States of Michigan, Wisconsin, Minnesota, Iowa, Missouri, Illinois, Indiana and Ohio. Import Supervisor. The official in charge of import inspection activities within each of the import field offices. Inedible. Adulterated, uninspected, or not intended for use as human food. Inhumane slaughter or handling in connection with slaughter. Slaughter or handling in connection with slaughter not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 through 1906, as amended by the Humane Methods of Slaughter Act of 1978, 92 Stat. 1069) and part 313 of this subchapter. "Inspected and passed" or "U.S. Inspected and Passed" or "U.S. Inspected and Passed by Department of Agriculture" (or any authorized abbreviation thereof). This term means that the product so identified has been inspected and passed under the regulations in this subchapter, and at the time it was inspected, passed, and identified, it was found to be not adulterated. Inspector. An inspector of the Pro gram. Inspector in charge. A designated program employee who is in charge of one or more official establishments within a circuit and is responsible to the circuit supervisor or his/her designee. Label. A display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article. Labeling. All labels and other written, printed, or graphic matter: (1) Upon any article or any of its containers or wrappers, or (2) Accompanying such article. Livestock. Cattle, sheep, swine, goat, horse, mule, or other equine. Meat. (1) The part of the muscle of any cattle, sheep, swine, or goats, which is skeletal or which is found in the tongue, in the diaphragm, in the heart, or in the esophagus, with or without the accompanying and overlying fat, and the portions of bone, skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and which are not separated from it in the process of dressing. It does not include the muscle found in the lips, snout, or ears. This term, as applied to products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats. (2) The product derived from the mechanical separation of the skeletal muscle tissue from the bones of livestock using the advances in mechanical meat/bone separation machinery and meat recovery systems that do not crush, grind, or pulverize bones, and from which the bones emerge comparable to those resulting from handdeboning (i.e., essentially intact and in natural physical conformation such that they are recognizable, such as loin bones and rib bones, when they emerge from the machinery) which meets the criteria of no more than 0.15 percent or 150 mg/100 gm of product for calcium (as a measure of bone solids content) within a tolerance of 0.03 percent or 30 mg. Meat broker. Any person engaged in the business of buying or selling carcasses, parts of carcasses, meat or meat food products of livestock on commission, or otherwise negotiating purchases or sales of such articles other than for his/her own account or as an employee of another person. Meat byproduct. Any part capable of use as human food, other than meat, which has been derived from one or more cattle, sheep, swine, or goats. This term, as applied to products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats. Meat food product. Any article capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, except those exempted from definition as a meat food product by the Administrator in specific cases or by the regulations in part 317 of this subchapter, upon a determination that they contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and provided that they comply with any requirements that are imposed in such cases or regulations as conditions of such exemptions to assure that the meat or other portions of such carcasses contained in such articles are not adulterated and that such articles are not represented as meat food products. This term, as applied to food products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats. Misbranded. This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances: (1) If its labeling is false or misleading in any particular; (2) If it is offered for sale under the name of another food; (3) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and immediately thereafter, the name of the food imitated; (4) If its container is so made, formed, or filled as to be misleading; (5) If in a package or other container unless it bears a label showing: (i) The name and place of business of the manufacturer, packer, or distributor; and (ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in part 317 of this subchapter with respect to the quantity of contents; (6) If any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (7) If it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by the regulations in part 319 of this subchapter unless: (i) It conforms to such definition and standard, and (ii) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food; (8) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by the regulations in part 319 of this subchapter, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; (9) If it is not subject to the provisions of paragraph (vv)(7)(ii) of this section unless its label bears: (i) The common or usual name of the food, if any there be, and (ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient, except as otherwise provided in part 317 of this subchapter; (10) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as is required by the regulations in part 317 of this subchapter. (11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact; except as otherwise provided by the regulations in part 317 of this subchapter; or (12) If it fails to bear, directly thereon or on its containers, when required by the regulations in part 316 or 317 of this subchapter, the inspection legend and, unrestricted by any of the foregoing, such other information as the Administrator may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition. Nonfood compound. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly, in the substance becoming a component or otherwise affecting the characteristics of meat food and meat products, excluding labeling and packaging materials as covered in part 317 of the subchapter. Official certificate. Any certificate prescribed by the regulations in this subchapter for issuance by an inspector or other person performing official functions under the Act. Official device. Any device prescribed by the regulations in part 312 of this subchapter for use in applying any official mark. Official establishment. Any slaughtering, cutting, boning, meat canning, curing, smoking, salting, packing, ren dering, or similar establishment at which inspection is maintained under the regulations in this subchapter. Official import inspection establishment. This term means any establishment, other than an official establishment as defined in paragraph (zz) of this section, where inspections are authorized to be conducted as prescribed in §327.6 of this subchapter. Official inspection legend. Any symbol prescribed by the regulations in this subchapter showing that an article was inspected and passed in accordance with the Act. Official mark. The official inspection legend or any other symbol prescribed by the regulations in this subchapter to identify the status of any article or animal under the Act. Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for meat products. Person. Any individual, firm, or corporation. Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for purposes of the Act and the regulations in this subchapter as under the Federal Food, Drug, and Cosmetic Act. Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed. Process authority. A person or organization with expert knowledge in meat production process control and relevant regulations. This definition does not apply to subpart G of part 318. Process schedule. A written description of processing procedures, consisting of any number of specific, sequential operations directly under the control of the establishment employed in the manufacture of a specific product, including the control, monitoring, verification, validation, and corrective action activities associated with production. This definition does not apply to subpart G of part 318. Product. Any carcass, meat, meat byproduct, or meat food product, capable of use as human food. Program. The organizational unit within the Department having the responsibility for carrying out the provisions of the Act. Program employee. Any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program. Regional Director. The official1 in charge of the program within each of the following regions: Northeastern Region-Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, and Virginia (except for Northwestern part). Southeastern Region- Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Virginia (Northwestern), West Virginia, Puerto Rico, and the Virgin Islands. North Central Region- Illinois, Indiana, Iowa, Michigan, Minnesota, Ohio, and Wisconsin. Southwestern Region Arkansas, Kansas, Louisiana, Missouri, Nebraska, New Mexico, Oklahoma, and Texas. Western Region— Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming, American Samoa, Guam, and the Northern Mariana Islands. Renderer. Any person engaged in the business of rendering carcasses or parts or products of the carcasses of any livestock except rendering conducted under inspection or exemption under Title I of the Act. Secretary. The Secretary of Agriculture of the United States or his/her delegate. Shipping container. The outside container (box, bag, barrel, crate, or other receptacle or covering) containing or wholly or partly enclosing any product packed in one or more immediate containers. State. Any State of the United States or the Commonwealth of Puerto Rico. 1 The addresses of the Regional Directors are as follows: Northeastern Region-Seventh Floor, 1421 Cherry Street, Philadelphia, PA 19102. Southeastern Region-Room 299 South, 1718 Peachtree Street, NW., Atlanta, GA 30309. North Central Region-607 East Second Street, Des Moines, IA 50309. Southwestern Region-Room 5-F41, 1100 Commerce Street, Dallas, TX 75201. Western Region-Room 620 Central Ave nue, Building 2C, Alameda, CA 94501. Supervision. The controls, as prescribed in instructions to Program employees, to be exercised by them over particular operations to insure that such operations are conducted in compliance with the Act and the regulations in this subchapter. Surgical anesthesia. A state of unconsciousness measured in conformity with accepted surgical practices. Territory. Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. U.S. Condemned. This term means that the livestock so identified has been inspected and found to be in a dying condition, or to be affected with any other condition or disease that would require condemnation of its car cass. U.S. Inspected and Condemned (or any authorized abbreviation thereof). This term means that the carcass, viscera, other part of carcass, or other product so identified has been inspected, found to be adulterated, and condemned under the regulations in this subchapter. U.S. Passed for Cooking. This term means that the meat or meat byproduct so identified has been inspected and passed on condition that it be cooked or rendered as prescribed by the regulations in part 315 of this chapter. U.S. Passed for Refrigeration. This term means that the meat or meat byproduct so identified has been inspected and passed on condition that it be refrigerated or otherwise handled as prescribed by the regulations in part 311 of this subchapter. U.S. Retained. This term means that the carcass, viscera, other part of carcass, or other product, or article so identified is held for further examination by an inspector to determine its disposal. U.S. Suspect. This term means that the livestock so identified is suspected of being affected with a disease or condition which may require its condemnation, in whole or in part, when slaughtered, and is subject to further examination by an inspector to determine its disposal. United States. The States, the District of Columbia, and the Territories of the United States. [35 FR 15554, Oct. 3, 1970] EDITORIAL NOTE: For FEDERAL REGISTER Citations affecting §301.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access. PART 302-APPLICATION OF INSPECTION AND OTHER REQUIREMENTS Sec. 302.1 Establishments requiring inspection. 302.2 Application of requirements in designated States or Territories; and to designated plants endangering public health. 302.3 Livestock and products entering official establishments. AUTHORITY: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. § 302.1 Establishments requiring inspection. (a) Inspection under the regulations in this subchapter is required at: (1) Every establishment, except as provided in §303.1 (a) and (b), or (c) of this subchapter, in which any livestock are slaughtered for transportation or sale as articles of commerce, or in which any products of, or derived from, carcasses of livestock are, wholly or in part, prepared for transportation or sale as articles of commerce, which are intended for use as human food; (2) Every establishment, except as provided in § 303.1 (a) and (b), or (d) of this subchapter, within any State or organized Territory which is designated pursuant to paragraph 301(c) of the Act, at which any livestock are slaughtered or any products of any livestock are prepared, for use as human food solely for distribution within such jurisdiction; and (3) Every establishment, except as provided in §303.1 (a) and (b) of this subchapter, that is designated by the Administrator pursuant to paragraph 301(c) of the Act as one producing adulterated products which would clearly endanger the public health. [35 FR 15556, Oct. 3, 1970, as amended at 36 FR 12002, June 24, 1971] § 302.2 Application of requirements in designated States or Territories; and to designated plants endangering public health. Special provisions with respect to establishments and their operations and transactions by any persons in designated States and Territories and with respect to establishments designated as producing adulterated products which clearly endanger public health, and the operators thereof, in any State or Territory appear in part 331 of this subchapter, and apply to such establishments, operations and transactions in lieu of the regulations elsewhere in this subchapter except insofar as such regulations are made applicable by the provisions in part 331 of this subchapter. [35 FR 15556, Oct. 3, 1970, as amended at 51 FR 29909, Aug. 21, 1986] |